Omni Instrument Tray

GUDID 15420045510296

Hologic, Inc.

Rigid optical hysteroscope

• Primary Device ID: 15420045510296
• NIH Device Record Key: 61c197b0-a93b-4e9e-92c5-a04bf7ac8903
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni Instrument Tray
• Version Model Number: 60-903
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045510296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182052

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

[15420045510296]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-02-28

On-Brand Devices [Omni Instrument Tray]

• 15420045510296: 60-903
• 15420045516595: Global Omni Instrument Tray